# K183083: Shoreline Cervical Interbody RT System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Feb 14, 2019 after 100 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 259 ancestors in all.
60 later devices descend from it; 6 cite it directly.
1 of 320 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K161081: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene, SeaSpine Orthopedics Corporation (2016) Summary page 4.
- K171046: SeaSpine Cambria System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K111675: VU C*Pod Intervertebral Body Fusion Device, Theken Spine, LLC (2011) Summary page 4.
- K101363: VU Cpod Intervertebral Bodu Fusion Device, Musculoskeletal Clinical Regulatory Advisers (2010) Summary page 4.
- K050058: Theken Reveal VBR System, Theken Surgical,Llc (2005) Summary page 4.
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 4.
- K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer, Globus Medical, Inc. (2018) Summary page 5.

## Most influential descendants
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), 39 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K201646: Shoreline ACS (Anterior Cervical System) (2020), 20 descendants of its own
- K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L  NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (2020), 18 descendants of its own
- K201073: Seaspine WaveForm C Interbody System (2020), 17 descendants of its own

## Indications for use
The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover. When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7). When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

Source page: https://510kreport.com/device/K183083
Methodology: https://510kreport.com/methodology